October 12, 2015
FDA’s priority review voucher program allows drug makers to receive expedited review of drug products intended to treat rare or neglected diseases (more details in our blog post here). The program was initiated by the Agency in an attempt to incentivize pharmaceutical companies to develop drugs that fill an unmet need existing for a serious condition. However, recent priority review vouchers have been selling at extraordinarily high prices and it seems FDA is becoming less and less enthusiastic about the program.
In a recent interview with Pharma & MedTech Business Intelligence, John Jenkins, Director of FDA’s Office of New Drugs, stated that the Agency’s historical issues and concerns with priority review vouchers have intensified as the number of companies lining up to cash in on them continues to increase.
Priority review vouchers shorten the Agency’s review time from a ten month time-frame to an inflexible period of six months. Essentially, the program allows companies to “purchase” these vouchers which, in turn, enable them to “cut” in front of all the other companies awaiting approval. This worries Jenkins, saying the program allows “sponsors to ‘purchase’ a priority review and removes FDA’s ability to set its work priorities and resource allocations based on the public health merit of the project. This approach is significantly different than other incentive programs (e.g., pediatric exclusivity) and the basic concepts that underlie the user fee programs which are rooted in speeding review for drugs that achieve public health priorities.”
In addition to disrupting the flow of approvals and the risk of extending the review time of other products, Jenkins also expressed concern regarding the set review time of six months. For example, he said that companies can redeem vouchers for products such as high cholesterol or diabetes, in which safe and effective treatments are already available. These products will be used by millions of patients after approval, making their applications much longer and more complex to review. Jenkins went on to say that “reviewing such an application in 6 months is very challenging and has the adverse impact of requiring managers and reviewers to refocus time and resources away from other important public health work, such as reviewing other applications for potentially much more serious conditions or drafting of guidance documents on issues related to drug development.”
Although there is a large user fee required for companies using the priority review voucher, Jenkins said that the intention of the fee was to provide the Agency with the additional resources necessary to facilitate the increased review time, “in reality the additional fees do not translate to additional staffing to support the division that must conduct the priority voucher review.” He said that the time it takes FDA to hire and train staff members in much longer than the 'lead time' FDA has to complete such activities. He then went on to state that “it is not logical or feasible for FDA to recruit and train staff only to be forced to let them go once the acute project is completed.”
However, despite FDA’s increasing concerns, the program continues to be extremely popular throughout the industry.
Do you have a product that you are seeking expedited FDA review and approval for? Are you simply trying to obtain approval without a priority review voucher? We can help. We have helped numerous clients with FDA submissions and have an extremely high rate of success. Using our proprietary approach, we have a track record of helping our clients achieve positive outcomes with FDA. To learn more about our services and how we can help you, please contact us.
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